Neoadjuvant Treatment of Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tamoxifen, Goserelin, Letrozole 2.5Mg Tab, Epirubicin.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial
Overview
Observational investigation of participants who are given neoadjuvant treatment for invasive breast cancer. The scope of the study is to collect information on standardized treatment results, to explore the causes of dose modification and its effect on efficacy, to explore potential prognostic factors, and to explore the long-term side effects of different treatment modalities.
Detailed description
The purpose of the study is based on the uniform application of international guidelines in Hungarian conditions. The standardized circumstances may lead to optimization of neoadjuvant therapy, it may facilitate subsequent data analysis, provide a basis for prospective clinical questions, and demonstrate improvement in pathologic complete remission (pCR) and overall survival (OS) compared to historical control. It may make possible to collect real-life data on each therapeutic option: efficacy, side effects, dose reduction, dose intensity, long-term consequences. The main scope is to collect prospective data to explore prognostic and predictive factors. The auxiliary aim is the assessment and comparison of quality of life during specific treatments and their side effects.
Interventions
- Drug Tamoxifen
endocrine therapy - Drug Goserelin
endocrine therapy - Drug Letrozole 2.5Mg Tab
endocrine therapy - Drug Epirubicin
chemotherapy - Drug cyclophosphamide
chemotherapy - Drug Docetaxel
chemotherapy - Drug paclitaxel
chemotherapy - Drug trastuzumab
biological treatment - Drug pertuzumab
biological treatment - Drug Capecitabine
chemotherapy
Primary outcome measures
- pathological complete remission rate [Time frame: 3 year, maximum]
Secondary outcome measures (4)
- invasive disease-free survival [Time frame: 10 years]
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [Time frame: 4 years]
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ BR45) [Time frame: 4 years]
- evaluation of side effects [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- Participant over 18 years of age .
- Histologically confirmed (core biopsy) invasive breast tumor.
- Tumor extent for the indication:
- regression must be achieved for radical surgical removal or
- regression is required for breast-conserving surgery or
- if hormone receptor (HR)-positive and Her2-: stage IIB (cT2N1 or cT3NO) - IIIC,
- if HR-negative: stage IIA (cT2N0 or cT0-1N1) - IIIC Note: In the case of a locally advanced, irresectable case, if the possibility of radical surgery later is a realistic goal, the participant may be included in the study.
- Appropriate general condition: ECOG 0-1
- Proper organ function
- Neutrophil count ≥ 1.5 G / l, platelet count ≥ 100 G / l, hemoglobin ≥ 10 g / dl
- Alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is less than 1.5 times the upper limit of the normal range
- bilirubin less than 1.5 times the upper limit of the normal range (except Gilbert's disease, where less than 3 times)
- creatinine less than 1.5 times the upper limit of the normal range or estimated glomerular filtration rate (eGFR) higher than 60 ml / min
Exclusion criteria
- Proven or suspected distant metastasis.
- No staging studies have been performed: at least chest x-ray, abdominal ultrasound. It is preferred to perform CT from the chest, abdomen, pelvic regions and bone isotope, or PET / CT if possible in case of lymph node involvement.
- Known significant heart disease: major arrhythmia or significant conduction defect (grade 2 or more), infarction or unstable angina within 6 months, cardiac collapse without appropriate therapy, long QT syndrome, heart failure (≥New York Heart Association/NYHA II)
- Other severe acute or chronic conditions (organic or psychiatric illness, laboratory abnormality) that, in the opinion of the treating physician, result in an unacceptable increase in the risk of chemotherapy and are contraindicated in routine clinical practice.
- Pregnancy or if the participant does not agree to use an appropriate non-hormonal method of contraception.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Hungary · 1 center
- National Institute of Oncolgy — Budapest
Identifiers
NCT: NCT05131893 · PANONC-1 Version: 1.1